[go: up one dir, main page]

WO2006047831A1 - Dispositif et procede de detection - Google Patents

Dispositif et procede de detection Download PDF

Info

Publication number
WO2006047831A1
WO2006047831A1 PCT/AU2005/001694 AU2005001694W WO2006047831A1 WO 2006047831 A1 WO2006047831 A1 WO 2006047831A1 AU 2005001694 W AU2005001694 W AU 2005001694W WO 2006047831 A1 WO2006047831 A1 WO 2006047831A1
Authority
WO
WIPO (PCT)
Prior art keywords
passageway
fluid
analyte
fluid flow
sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/AU2005/001694
Other languages
English (en)
Inventor
Philip Gerard Toye
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Agen Biomedical Ltd
Original Assignee
Agen Biomedical Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Agen Biomedical Ltd filed Critical Agen Biomedical Ltd
Publication of WO2006047831A1 publication Critical patent/WO2006047831A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/536—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502746—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the means for controlling flow resistance, e.g. flow controllers, baffles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0816—Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/08—Regulating or influencing the flow resistance
    • B01L2400/084—Passive control of flow resistance

Definitions

  • This invention relates generally to a device and method for determining the presence of an analyte in a test sample. More particularly, the present invention relates to a device and method for use in an agglutination assay process or test. It is particularly well suited, but not exclusively so, to processes and tests for agglutination reactions (e.g., haemagglutination reactions).
  • the antigen-antibody reaction is the basis for all immunological test methods. Certain proteins known as antibodies are produced by mammals in response to the presence of an antigen which is often another protein or can be a carbohydrate or other component. This normal body response to foreign substances has led to the development of a number of techniques which are used to diagnose various diseases, disorders and physiological conditions.
  • the component of the antigen-antibody reaction to be detected is defined as an analyte while the other corresponding component is considered the ligand.
  • the analyte may be an antigen or an antibody.
  • This member can be a bibulous material (paper), a membrane or a reagent film.
  • the dry and stable reagent may then be contained within a reactive zone of the device.
  • analysis fluid makes contact with the dry reagent, the reagents are at least partially resolubilised to react with an analyte of interest.
  • the present applicant provides several commercial assays which rely on specific reagents which, when added to a patient's sample, result in agglutination of the patient's red blood cells if the sample is positive. This is usually due to interaction between antibody-based reagents in the test kit, the analyte of interest in a patient's plasma and patient red blood cells. This haemagglutination is readily observed as clumping of the red blood cells.
  • the existing assays are supplied in kit form, which includes three small plastic vials containing the buffer, test reagent and positive control together with pipette stirrers and plastic plates.
  • the vials must be stored at 4° C.
  • the existing assays are reasonably reliable and have widespread acceptance, they involve the necessity of considerable handling of material with subsequent risk of contamination and/or escape of dangerous organisms. Further, the assays involve a number of steps including the need to add specific volumes of fluids, thereby increasing the chance of variability in test technique. Individual proficiency can therefore become an issue in the reliability of the results.
  • the present invention provides methods and devices for determining the presence or quantity of an analyte in a fluid sample. These methods and devices are generally based on (1) the formation of an agglutination complex in the presence of the analyte and (2) the use of a fluid passageway that includes a first part and a second part. The first part of the passageway permits the flow of the agglutination complex downstream to the second part and the second part impedes the downstream flow of the agglutination complex. Detection of the agglutination complex in or adjacent to the second part indicates the presence of the analyte in the fluid sample.
  • the present invention provides assay devices, which include at least one passageway that comprises a wall on which one or more assay reagents (e.g., an agglutinating agent or agglutinable component) are releasably disposed thereon.
  • assay reagents e.g., an agglutinating agent or agglutinable component
  • the articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article.
  • an element means one element or more than one element.
  • the present invention provides methods for determining the presence of an analyte in a fluid sample. These methods generally comprise:
  • cross section refers to a surface or shape of a passageway that is exposed, or a section of the passageway made, by a plane cutting the passageway transversely, especially at right angles, to an axis, including the longest axis, of the passageway.
  • the fluid flow cross section of the first part of the passageway may have a shape, surface or cross sectional area that permits the flow of an agglutination complex downstream to the second part and the fluid flow cross section of the second part has a shape, surface or cross sectional area that impedes the flow therethrough of some or all of the agglutination complex.
  • the cross section of the passageway may have any suitable shape that has the fluid flow characteristics referenced herein, including circular, ovoid, elliptical, square, rectangular, irregular, U-shaped, V-shaped or with internal projections.
  • the passageway may contain one or more bends, curves bifurcations and the like, which regulate flow of fluid or the agglutination complex.
  • the passageway may have a surface characteristic that regulates the flow of fluid and/or the agglutination complex to a downstream location of the passageway.
  • the surface characteristic is provided at least in part by a wall of the passageway that comprises at least one flow-regulating component that is capable of interacting (e.g., binding, reacting etc) with a component of the agglutination complex including, for example, the ligand, the analyte and the agglutinable component.
  • the surface of the passageway includes an antibody or antibody fragment that binds to the analyte. In illustrative examples of this type, the antibody or antibody fragment binds to a different epitope on the analyte than the one to which the ligand binds.
  • the passageway further comprises a third part that receives components of the contacted sample that are permitted to flow downstream of the second part, wherein the third part is in fluid flow communication with the first part and the second part.
  • the third part may include an immobilised capturing element that captures such components (e.g., free ligand and/or agglutinable component).
  • the agglutination complex is associated with a first detectable signal and the agglutinable component is associated with a second detectable signal and the method further comprises comparing the first detectable signal in or adjacent to the second part and the second detectable signal in the second or third parts to provide a quantitative or semi-quantitative assay of the analyte in the fluid sample.
  • the ligand and optionally other assay components are releasably disposed in the first part of the passageway and the method comprises contacting the fluid sample with the ligand and optionally other assay components in that part.
  • the first part of the passageway has a fluid flow cross section that permits mixing of the analyte, if present in the fluid sample, with the ligand and the agglutinable component.
  • the first part of the passageway is of appropriate shape or dimensions or has fluid flow surface characteristics, to permit agglutination to occur in a positive sample (i.e., a sample that contains the analyte) before the fluid sample arrives at the second part of the passageway.
  • ligand associates with an agglutinable component is meant: (i) direct attachment of the agglutinable component to the ligand or a subsequent reaction product of the ligand; and (ii) indirect attachment of the agglutinable component to the ligand or a subsequent reaction product of the ligand, e.g., attachment of the agglutinable component to another assay reagent that subsequently binds to the ligand.
  • the second part does not permit some or all of the agglutination complex to flow therethrough. In some embodiments, the second part does not permit at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% of the agglutination complex to flow therethrough.
  • the analyte is selected from an antigen, a hapten, an antibody, a protein, a peptide, an amino acid, a nucleic acid, a hormone, a steroid, a vitamin, a carbohydrate, a lipid, a blood clotting factor, a pathogenic organism, a natural or synthetic chemical substance, a contaminant, a drug including those administered for therapeutic purposes as well as those administered for illicit purposes, and metabolites of or antibodies to any of the above substances.
  • the analyte and the ligand will each be member of a binding pair, illustrative examples of which include antigens and antibodies, lectins and carbohydrates, complementary peptides, protein, carbohydrate and nucleic acid molecules, enzyme inhibitors and enzymes, Protein A and IgG, Fc receptors and immunoglobulins, as well as effector and receptor molecules.
  • the agglutinable component is typically a particle which is suitably but not exclusively selected from polymeric particles (e.g., latex particles), ceramic particles (e.g., silica particles), metal particles, liposomes, carbon particles, bacteria and erythrocytes.
  • the particle may comprise one or more dyes or fluorescent, phosphorescent or other light-emitting material, either singly or in combination.
  • the agglutinable component may be conjugated with the ligand or it may be a separate component. In the latter case, the ligand suitably comprises a moiety (e.g., an antibody or antibody fragment) that is interactive with the agglutinable component.
  • the ligand comprises an agglutinating agent that agglutinates the agglutinable component.
  • agglutinating agents include bifunctional antibody conjugates in which one antibody or antibody fragment binds, for example, to red blood cells and the other antibody or antibody fragment binds, for example, to D-dimer.
  • Representative assays that use such bifunctional antibody conjugates include the SimpliRED® assay (Agen Biomedical Limited, Brisbane, Australia).
  • These devices generally comprise: at least one inlet port; and, for each analyte, at least one passageway that is in fluid flow communication with the at least one inlet port and that changes in fluid flow cross section or surface characteristics downstream of the at least one inlet port, wherein a fluid sample deposited in an individual inlet port travels along a flow path between a proximal end and a distal end of a respective passageway.
  • the fluid flow cross section or surface characteristic of an individual passageway at a location between its proximal and distal ends changes sufficiently to impede flow along the pathway of the agglutination complex.
  • the fluid flow cross section of an individual passageway is defined at least in part by the cross sectional area of the passageway itself.
  • the cross sectional area of the passageway decreases in size from the first part to the second part. Representative dimensions for this decrease are from about 500 - 3000 ⁇ m to about 2 - 10 ⁇ m in width or diameter. In specific embodiments, the sizes may range between about 800 ⁇ m - 1400 ⁇ m decreasing to about 2 ⁇ m - 20 ⁇ m in width or diameter. Other ranges may be suitable.
  • the fluid flow cross section of an individual passageway is defined at least in part by the pore size of a filter.
  • the second part of the passageway is defined by a pore of the filter.
  • the fluid flow cross section of an individual passageway is defined at least in part by a pair of spaced pillars disposed within a conduit.
  • the second part of the passageway is defined by a plurality of spaced pillars disposed within the conduit, and individual pairs of pillars are suitably spaced to allow passage between the pillars of components of the contacted sample other than some or all of the agglutination complex.
  • the pillars are columnar but may be of any suitable cross sectional shape.
  • individual passageways are dimensioned to provide a positive zone area and a negative zone area. Where multiple stepdown decreases in fluid flow cross sectional area are provided, a semi-quantitative result may be obtained.
  • an individual passageway has a fluid flow cross sectional area that permits the flow of fluid therethrough by capillary action.
  • the passageway is suitably formed of a capillary conduit or channel.
  • an individual passageway has a fluid flow cross sectional area that does not permit the flow of fluid therethrough by capillary action.
  • the method suitably further comprises forcing the contacted sample along the passageway (e.g., using centrifugal force air pressure, vacuum, electroosmosis, heating and the like).
  • an individual passageway comprises at least two spaced segments, wherein an individual downstream segment inhibits the passage of components of the contacted sample whose passage was permitted by an adjacent upstream segment.
  • the fluid flow cross sectional area of an individual passageway gradually decreases along at least a portion of the pathway, which gradually inhibits the passage of smaller components of the contacted sample.
  • an individual passageway has a single stepped decrease in fluid flow cross sectional area.
  • an individual passageway may have two or more stepped decreases in fluid flow cross sectional areas.
  • an individual passageway has a gradual or constant decrease in fluid flow cross sectional area.
  • the device comprises, for an individual analyte, multiple parallel passageways that form subconduits of a larger conduit.
  • the device comprises a plurality of such conduits, wherein the number of conduits corresponds to the number of analytes testable by the device.
  • an individual subconduit may have a single stepped decrease in fluid flow cross sectional area, which is preferably aligned or in register with a similar decrease in fluid flow cross sectional areas in other subconduits.
  • the subconduits may have two or more stepped decreases in fluid flow cross sectional area, again, preferably, with each aligned or in register with corresponding stepped decreases in other parallel subconduits.
  • individual subconduits are in fluid flow communication with a plurality of downstream subconduits that have smaller fluid flow cross sectional areas than the upstream subconduit.
  • the individual passageways are in fluid flow communication with a reservoir that receives the fluid sample and/or other fluids.
  • the other fluids may comprise one or more buffer solutions or wash solutions, or fluids containing testing reagents.
  • the reservoir comprises a capturing element that captures or immobilises components (any free ligand and/or agglutinable component) that flow downstream of the decrease in fluid flow cross section or surface characteristic of the passageway(s).
  • the reservoir may contain an absorbent material to facilitate the flow of fluid sample and/or other fluids.
  • the passageway(s) is (are) in fluid communication with a at least one vent for venting fluid (e.g., air) to atmosphere.
  • fluid e.g., air
  • the device comprises a body or housing that is preferably elongate and formed with a planar or slide-like configuration.
  • the body or housing may be formed from two sections. The sections may be halves which are joined face-to-face.
  • the body or housing may comprise a fluid sample inlet compartment that communicates with the inlet port.
  • the inlet compartment may be a well or a chamber.
  • the body or housing comprises a window that permits viewing of the change in fluid flow cross section or surface characteristic of the passage(s) and viewing, for example, of any immobilised agglutination complex.
  • the device further comprises a ligand for detecting one or more analytes.
  • the ligand may be releasably disposed on a wall of the inlet port or preferably on a wall of an individual passageway adjacent to its proximal end. Where a plurality of passageways are supplied, a range of different ligands may be applied to conduct simultaneous testing of the fluid sample for different analytes.
  • kits for detecting at least one analyte These kits generally comprise a device as broadly described above and reagents required for detecting the or each analyte.
  • the kits may optionally include appropriate reagents for detection of labels, positive and negative controls, washing solutions, dilution buffers, calibration standards and the like.
  • the kits comprise distinct containers for each individual reagent.
  • the kits are supplied with instructions, which instruct the user how to use the device and method as broadly described above.
  • the present invention provides assay devices for determining the presence or quantity of an analyte.
  • These devices generally comprise at least one passageway that comprises a wall having one or more assay reagents releasably disposed thereon.
  • the or each assay reagent is in dry form on the wall surface.
  • the passageway permits capillary flow of a fluid sample from a location upstream of the assay reagent(s).
  • the passageway is dimensioned or has a surface to permit contact and mixing of the assay reagent(s) with the fluid sample and downstream flow of the contacted fluid sample.
  • the assay reagent(s) comprise(s) an agglutinable component or agglutination agent as broadly described above.
  • Figure 1 is a top plan view of a first embodiment of the test device of the present invention
  • Figure 3 is a top plan view of the device of Figure 1 showing a negative result
  • Figure 4 is a top plan view of the device of Figure 1 showing a positive result. DESCRIPTION OF PREFERRED EMBODIMENTS
  • Passage of the sample may be enhanced by addition of other fluids such as a buffer or wash solutions.
  • the presence of fluid in the proximal portion 16 will, at least partially, resolubilise the reagent, thereby leading to mixing with the testing sample and institution of the diagnostic reaction if the target substance is present.
  • the capillary conduit can be completely contained within the substance of the body so that there is no external leakage of the material. Alternatively, the conduit may comprise an open channel through which the fluid sample and reactants may pass.
  • An intermediate section 20 is provided and comprises a series of parallel capillary channels 22.
  • a distal zone 24 comprises a series of parallel narrow channels in the form of narrow capillary channels.
  • the transfer from broad capillary channels to narrow capillary channels occurs at interface 26, thereby providing a well-demarcated transition between the broad and narrow channels.
  • the capillary conduit 18 is in fluid communication with a reservoir 28 adapted to receive any transferred fluid, either sample or other material, and provide an outlet for the capillary transfer of materials.
  • the reservoir may be vented to the outside to avoid increased pressure resisting capillary transfer. Additionally or alternatively, the reservoir may have an absorbent material located in it to receive and retain any fluid.
  • Figure 2 shows a variation of testing device 110 with a port 112 which feeds into a manifold 130 which subsequently feeds into parallel capillary conduits 131, 132, 133 all with a similar structure to that described in relation to Figure 1.
  • each of the conduits may have a different reagent located in the proximal zone 116 to provide a multiple testing capacity.
  • One of the capillary channels may comprise a positive test reagent and one may comprise a negative test reagent for checking of testing device integrity.
  • Figure 3 shows an example of a negative test result in an arrangement similar to that of Figure 1.
  • the test sample 40 is shown contained in the reservoir 28. It has therefore flowed through the entire length of the testing conduit without being obstructed.
  • the capillary conduit may incorporate two or more stepdown shoulders to provide a gradation of results and therefore give a more informative visual result.
  • This provides a semi-quantitative result which may be calibrated or classified according to a range such as strong, intermediate, weak and negative.
  • a variety of manufacturing processes all well known to those skilled in the art may be applied to provide the present test device.
  • a first test device section and a second test device section are fused together during production to form the test body.
  • the reagent may be placed on one of the sections and dried or, alternatively, placed on both prior to joining.
  • Beneficial methods of application of the reagent may include screen or inkjet printing, spraying by use of an airbrush technique or conventional dispensing of quantities using a positive displacement microvolume dispenser.
  • the reagents may be dried by stationary or forced air which may be heated or at room temperature.
  • the reagent may be dried in the presence of stabilisers and agents which facilitate resolubilisation.
  • the capillary conduit and the capillary channels may be achieved by etching and also by a punch-out and laminating technique, by embossing, heat stamping or by flow injection or compression moulding. Injection or compression moulding may be preferred because of their accuracy and precision. This accuracy may be important to provide appropriate flow dynamics through the capillary conduits and capillary channels.
  • the first test device section and the second test device section may be constructed or composed of the same or different material and may be fused, for example, by adhesive tape, adhesive bonding, ultrasonic welding or even by a mechanical snap-in technique.
  • a clear plastic, glass or other such material for the body and to define the capillary conduits and capillary channels.
  • the body may be formed from polycarbonate, polymethylmethacrylate or polystyrene.
  • Advantages of the present invention include an enclosed reaction area to reduce the possibility of contamination from infected blood samples, removal of any necessity to rock a reaction combination, fewer procedural steps, long-term stability of the reagents at room temperature and a more objective indication of agglutination and, in particular, haemagglutination.
  • blood is applied to the sample port and flows into and through a region of parallel capillary channels, the first part of which is coated with the dried reagent.
  • the reagent is solubilised and mixes with the blood, causing haemagglutination in a positive sample.
  • the channels in this region are wide enough to allow the passage of agglutinated blood cells.
  • the mixture eventually reaches a region of narrow capillary channels to allow the passage of individual red blood cells but not agglutinated cells.
  • a negative sample all of the blood sample reaches and accumulates in the reservoir.
  • a positive sample all or some of the sample may be retarded at the junction of the wide and narrow capillary tube.
  • the device may be used to type human blood or blood from other species, wherein the reagent is an antibody or other agglutinating reagent directed against red blood cell typing antigens. It is further within the scope of this invention that the reagent is an active component of a particulate agglutination assay where the particles are, for example, coloured latex particles or fixed red blood cells conjugated to an antibody or antigen reactive with the analyte of interest.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • Dispersion Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

La présente invention concerne des procédés et des dispositifs permettant de déterminer la présence ou la quantité d'un analyte dans un échantillon de fluide. Ces procédés et ces dispositifs sont fondés sur (1) la formation d'un complexe d'agglutination en présence de l'analyte et (2) sur l'utilisation d'un passage de fluide qui comprend une première partie et une seconde partie. La première partie du passage permet l'écoulement du complexe d'agglutination amont vers la seconde partie et la seconde partie empêche l'écoulement amont du complexe d'agglutination. La détection du complexe d'agglutination dans la seconde partie ou à côté de celle-ci indique la présence de l'analyte dans l'échantillon de fluide.
PCT/AU2005/001694 2004-11-03 2005-11-03 Dispositif et procede de detection Ceased WO2006047831A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US62489804P 2004-11-03 2004-11-03
US60/624,898 2004-11-03

Publications (1)

Publication Number Publication Date
WO2006047831A1 true WO2006047831A1 (fr) 2006-05-11

Family

ID=36318830

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2005/001694 Ceased WO2006047831A1 (fr) 2004-11-03 2005-11-03 Dispositif et procede de detection

Country Status (1)

Country Link
WO (1) WO2006047831A1 (fr)

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014110456A1 (fr) * 2013-01-11 2014-07-17 Becton, Dickinson And Company Dispositif d'analyse hors laboratoire à bas coût
WO2014172236A1 (fr) * 2013-04-15 2014-10-23 Becton, Dickinson And Company Dispositif de séparation de fluide biologique et système de séparation et d'examen de fluide biologique
US9380973B2 (en) 2013-04-15 2016-07-05 Becton, Dickinson And Company Biological fluid sampling transfer device and biological fluid separation and testing system
US9380972B2 (en) 2013-04-15 2016-07-05 Becton, Dickinson And Company Biological fluid collection device and biological fluid collection and testing system
US9408568B2 (en) 2013-04-15 2016-08-09 Becton, Dickinson And Company Biological fluid sampling device
US9517026B2 (en) 2013-04-15 2016-12-13 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
US9523682B2 (en) 2011-11-16 2016-12-20 Becton, Dickinson And Company Methods and systems for detecting an analyte in a sample
US9549700B2 (en) 2013-04-15 2017-01-24 Becton, Dickinson And Company Biological fluid sampling transfer device and biological fluid separation and testing system
US9597028B2 (en) 2013-04-15 2017-03-21 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
US9649061B2 (en) 2015-03-10 2017-05-16 Becton, Dickinson And Company Biological fluid micro-sample management device
US9693723B2 (en) 2014-10-14 2017-07-04 Becton, Dickinson And Company Blood sample management using open cell foam
US9797899B2 (en) 2013-11-06 2017-10-24 Becton, Dickinson And Company Microfluidic devices, and methods of making and using the same
US10018640B2 (en) 2013-11-13 2018-07-10 Becton, Dickinson And Company Optical imaging system and methods for using the same
US10080516B2 (en) 2013-04-15 2018-09-25 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
WO2018226161A1 (fr) * 2017-06-08 2018-12-13 National University Of Singapore Dispositif de collecte et de traitement de sang
US10154808B2 (en) 2013-04-15 2018-12-18 Becton, Dickinson And Company Biological fluid separation device and biological fluid separation and testing system
US10194851B2 (en) 2013-04-15 2019-02-05 Becton, Dickinson And Company Blood sampling transfer device and blood separation and testing system
US10238325B2 (en) 2013-04-15 2019-03-26 Becton, Dickinson And Company Medical device for collection of a biological sample
US10342471B2 (en) 2013-04-15 2019-07-09 Becton, Dickinson And Company Biological fluid transfer device and biological fluid sampling system
US10578606B2 (en) 2015-09-01 2020-03-03 Becton, Dickinson And Company Depth filtration device for separating specimen phases
US10791975B2 (en) 2013-04-15 2020-10-06 Becton, Dickinson And Company Biological fluid transfer device and biological fluid sampling system
US10925530B2 (en) 2013-04-15 2021-02-23 Becton, Dickinson And Company Blood sampling transfer device
US10925532B2 (en) 2015-08-06 2021-02-23 Becton, Dickinson And Company Biological fluid collection device and biological fluid collection system
US11298061B2 (en) 2014-10-14 2022-04-12 Becton, Dickinson And Company Blood sample management using open cell foam
AT525192A1 (de) * 2021-06-15 2023-01-15 Genspeed Biotech Gmbh Mikrofluidischer chip
CN117269483A (zh) * 2023-11-22 2023-12-22 昊朗科技（佛山）有限公司 一种基于凝集反应的检测试纸及其测试方法

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4756884A (en) * 1985-08-05 1988-07-12 Biotrack, Inc. Capillary flow device
US4775515A (en) * 1986-11-18 1988-10-04 Cottingham Hugh V Agglutinographic slide
WO1990009596A1 (fr) * 1989-02-10 1990-08-23 David Roger Vale Controle de liquides
US5019351A (en) * 1988-04-29 1991-05-28 Hoffman-La Roche Inc. Agglutination reaction slide
WO1992008974A1 (fr) * 1990-11-16 1992-05-29 Abbott Laboratories Dispositif de reaction d'agglutination ameliore utilisant une matiere poreuse selectivement impregnee
WO1992008973A1 (fr) * 1990-11-16 1992-05-29 Abbott Laboratories Dispositif de reaction d'agglutination ameliore utilisant une matiere poreuse absorbante
EP0321736B1 (fr) * 1987-12-23 1994-06-01 Abbott Laboratories Dispositif pour réaction d'agglutination
WO1999035497A2 (fr) * 1998-01-08 1999-07-15 Bio-Diagnostics Limited Dispositif pour tester des liquides
WO2001068238A2 (fr) * 2000-03-14 2001-09-20 Micronics, Inc. Cartouche d'analyse microfluidique
EP1450159A2 (fr) * 2003-02-24 2004-08-25 Ortho-Clinical Diagnostics, Inc. Procédé et appareil de détection de l'agglutinement des analyses
WO2004083859A1 (fr) * 2003-03-18 2004-09-30 Platform Diagnostics Limited Dispositif d'analyse d'echantillon base sur l'agglutination

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4756884A (en) * 1985-08-05 1988-07-12 Biotrack, Inc. Capillary flow device
US4775515A (en) * 1986-11-18 1988-10-04 Cottingham Hugh V Agglutinographic slide
EP0321736B1 (fr) * 1987-12-23 1994-06-01 Abbott Laboratories Dispositif pour réaction d'agglutination
US5019351A (en) * 1988-04-29 1991-05-28 Hoffman-La Roche Inc. Agglutination reaction slide
WO1990009596A1 (fr) * 1989-02-10 1990-08-23 David Roger Vale Controle de liquides
WO1992008974A1 (fr) * 1990-11-16 1992-05-29 Abbott Laboratories Dispositif de reaction d'agglutination ameliore utilisant une matiere poreuse selectivement impregnee
WO1992008973A1 (fr) * 1990-11-16 1992-05-29 Abbott Laboratories Dispositif de reaction d'agglutination ameliore utilisant une matiere poreuse absorbante
WO1999035497A2 (fr) * 1998-01-08 1999-07-15 Bio-Diagnostics Limited Dispositif pour tester des liquides
WO2001068238A2 (fr) * 2000-03-14 2001-09-20 Micronics, Inc. Cartouche d'analyse microfluidique
EP1450159A2 (fr) * 2003-02-24 2004-08-25 Ortho-Clinical Diagnostics, Inc. Procédé et appareil de détection de l'agglutinement des analyses
WO2004083859A1 (fr) * 2003-03-18 2004-09-30 Platform Diagnostics Limited Dispositif d'analyse d'echantillon base sur l'agglutination

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
JOHN M A ET AL: "The simpliRED D dimer test: a novel assay for the detection of crosslinked fibrin degradation products in whole blood.", THROMBOSIS RESEARCH., vol. 58, no. 3, 1 May 1990 (1990-05-01), pages 273 - 281 *

Cited By (51)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9523682B2 (en) 2011-11-16 2016-12-20 Becton, Dickinson And Company Methods and systems for detecting an analyte in a sample
WO2014110456A1 (fr) * 2013-01-11 2014-07-17 Becton, Dickinson And Company Dispositif d'analyse hors laboratoire à bas coût
CN104755925B (zh) * 2013-01-11 2017-06-23 贝克顿·迪金森公司 低成本的定点照护测定装置
CN104755925A (zh) * 2013-01-11 2015-07-01 贝克顿·迪金森公司 低成本的定点照护测定装置
US9678065B2 (en) 2013-01-11 2017-06-13 Becton, Dickinson And Company Low-cost point-of-care assay device
US10154808B2 (en) 2013-04-15 2018-12-18 Becton, Dickinson And Company Biological fluid separation device and biological fluid separation and testing system
US10028690B2 (en) 2013-04-15 2018-07-24 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
US9517026B2 (en) 2013-04-15 2016-12-13 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
US9380972B2 (en) 2013-04-15 2016-07-05 Becton, Dickinson And Company Biological fluid collection device and biological fluid collection and testing system
US9549700B2 (en) 2013-04-15 2017-01-24 Becton, Dickinson And Company Biological fluid sampling transfer device and biological fluid separation and testing system
US9597028B2 (en) 2013-04-15 2017-03-21 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
US12082931B2 (en) 2013-04-15 2024-09-10 Becton, Dickinson And Company Blood sampling transfer device
US9380973B2 (en) 2013-04-15 2016-07-05 Becton, Dickinson And Company Biological fluid sampling transfer device and biological fluid separation and testing system
CN104155435A (zh) * 2013-04-15 2014-11-19 贝克顿·迪金森公司 生物流体分离装置和生物流体分离与检验系统
US11974846B2 (en) 2013-04-15 2024-05-07 Becton, Dickinson And Company Biological fluid transfer device and biological fluid sampling system
US10238325B2 (en) 2013-04-15 2019-03-26 Becton, Dickinson And Company Medical device for collection of a biological sample
US9808192B2 (en) 2013-04-15 2017-11-07 Becton, Dickinson And Company Biological fluid sampling transfer device and biological fluid separation and testing system
US9833182B2 (en) 2013-04-15 2017-12-05 Becton, Dickinson And Company Biological fluid separation device and biological fluid separation and testing system
US11291393B2 (en) 2013-04-15 2022-04-05 Becton, Dickinson And Company Medical device for collection of a biological sample
US10925530B2 (en) 2013-04-15 2021-02-23 Becton, Dickinson And Company Blood sampling transfer device
US10827965B2 (en) 2013-04-15 2020-11-10 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
US10791975B2 (en) 2013-04-15 2020-10-06 Becton, Dickinson And Company Biological fluid transfer device and biological fluid sampling system
US10080516B2 (en) 2013-04-15 2018-09-25 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
US10136849B2 (en) 2013-04-15 2018-11-27 Becton, Dickinson And Company Biological fluid collection device and biological fluid separation and testing system
US10342471B2 (en) 2013-04-15 2019-07-09 Becton, Dickinson And Company Biological fluid transfer device and biological fluid sampling system
WO2014172236A1 (fr) * 2013-04-15 2014-10-23 Becton, Dickinson And Company Dispositif de séparation de fluide biologique et système de séparation et d'examen de fluide biologique
US10194851B2 (en) 2013-04-15 2019-02-05 Becton, Dickinson And Company Blood sampling transfer device and blood separation and testing system
US9408568B2 (en) 2013-04-15 2016-08-09 Becton, Dickinson And Company Biological fluid sampling device
CN104155435B (zh) * 2013-04-15 2019-02-19 贝克顿·迪金森公司 生物流体分离装置和生物流体分离与检验系统
CN109613223A (zh) * 2013-04-15 2019-04-12 贝克顿·迪金森公司 生物流体分离装置和生物流体分离与检验系统
US9797899B2 (en) 2013-11-06 2017-10-24 Becton, Dickinson And Company Microfluidic devices, and methods of making and using the same
US10073093B2 (en) 2013-11-06 2018-09-11 Becton, Dickinson And Company Microfluidic devices, and methods of making and using the same
US10663476B2 (en) 2013-11-13 2020-05-26 Becton, Dickinson And Company Optical imaging system and methods for using the same
US10018640B2 (en) 2013-11-13 2018-07-10 Becton, Dickinson And Company Optical imaging system and methods for using the same
US11134875B2 (en) 2014-10-14 2021-10-05 Becton, Dickinson And Company Blood sample management using open cell foam
US9693723B2 (en) 2014-10-14 2017-07-04 Becton, Dickinson And Company Blood sample management using open cell foam
US10219731B2 (en) 2014-10-14 2019-03-05 Becton, Dickinson And Company Blood sample management using open cell foam
US10888261B2 (en) 2014-10-14 2021-01-12 Becton, Dickinson And Company Blood sample management using open cell foam
US11298061B2 (en) 2014-10-14 2022-04-12 Becton, Dickinson And Company Blood sample management using open cell foam
US10595762B2 (en) 2014-10-14 2020-03-24 Becton, Dickinson And Company Blood sample management using open cell foam
US9873117B2 (en) 2015-03-10 2018-01-23 Becton, Dickinson And Company Biological fluid micro-sample management device
US9649061B2 (en) 2015-03-10 2017-05-16 Becton, Dickinson And Company Biological fluid micro-sample management device
US10925532B2 (en) 2015-08-06 2021-02-23 Becton, Dickinson And Company Biological fluid collection device and biological fluid collection system
US11793432B2 (en) 2015-08-06 2023-10-24 Becton, Dickinson And Company Biological fluid collection device and biological fluid collection system
US11366095B2 (en) 2015-09-01 2022-06-21 Becton, Dickinson And Company Depth filtration device for separating specimen phases
US10578606B2 (en) 2015-09-01 2020-03-03 Becton, Dickinson And Company Depth filtration device for separating specimen phases
US11808757B2 (en) 2015-09-01 2023-11-07 Becton, Dickinson And Company Depth filtration device for separating specimen phases
WO2018226161A1 (fr) * 2017-06-08 2018-12-13 National University Of Singapore Dispositif de collecte et de traitement de sang
AT525192A1 (de) * 2021-06-15 2023-01-15 Genspeed Biotech Gmbh Mikrofluidischer chip
CN117269483B (zh) * 2023-11-22 2024-03-29 昊朗科技（佛山）有限公司 一种基于凝集反应的检测试纸及其测试方法
CN117269483A (zh) * 2023-11-22 2023-12-22 昊朗科技（佛山）有限公司 一种基于凝集反应的检测试纸及其测试方法

Similar Documents

Publication Publication Date Title
WO2006047831A1 (fr) Dispositif et procede de detection
EP2902784B1 (fr) Dispositif de dosage utilisant un milieu poreux
KR100885074B1 (ko) 미세유로형 센서 복합 구조물
JP4351539B2 (ja) 遠心力及び／又は毛管力によって流体を正確に移動し、操作する方法及び装置
JP6143734B2 (ja) 流体コネクタおよびマイクロ流体システム
US4426451A (en) Multi-zoned reaction vessel having pressure-actuatable control means between zones
CN1953802B (zh) 流体递送系统和方法
US20110124130A1 (en) Device and method for analysis of samples with depletion of analyte content
CN101326441B (zh) 用于快速诊断的试验装置
US20090087925A1 (en) Devices and methods for analysis of samples with depletion of analyte content
CA2658795A1 (fr) Dispositif d'analyse d'un echantillon biologique
WO2005029073A2 (fr) Procedes et dispositif de dosage chromatographique
CN104428675A (zh) 用于即时检测性免疫层析分析的冻干缀合物结构体、使用其进行免疫检测的试剂盒,以及使用该试剂盒进行分析的方法
US20080240996A1 (en) Method of detecting analytes in a microfluidic sample and a system for performing the same
WO2012075256A2 (fr) Dispositif doseur d'échantillon et dispositif d'analyse comportant la dilution intégrée de l'échantillon
KR102007164B1 (ko) 다중 미세유로를 구비한 하이브리드 신속 진단 키트
WO2012075258A2 (fr) Procédé de dosage immunologique ratiométrique et dispositif d'analyse sanguine
WO2008156491A2 (fr) Dispositifs et procédés pour l'analyse d'échantillons avec épuisement de la teneur en analyte
US9784733B1 (en) Rapid diagnostic test device by driven flow technology
US11353451B2 (en) PoC test system and method
JP2005257468A (ja) バイオセンサ
US20230127232A1 (en) Flow assay cartridge
CN115582154A (zh) 一种用于免疫检测的微流控芯片
CN118491577A (zh) 磁珠发光微流控芯片及新冠IgM抗体检测方法
WO2019175744A1 (fr) Système et procédés pour l'analyse rapide d'échantillons biologiques

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KM KN KP KR KZ LC LK LR LS LT LU LV LY MA MD MG MK MN MW MX MZ NA NG NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SM SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): BW GH GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LT LU LV MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: DE

WPC Withdrawal of priority claims after completion of the technical preparations for international publication

Ref document number: 60/624,898

Country of ref document: US

Free format text: WITHDRAWN AFTER TECHNICAL PREPARATION FINISHED

122 Ep: pct application non-entry in european phase

Ref document number: 05798984

Country of ref document: EP

Kind code of ref document: A1